Hota Susy S, Surangiwala Salman, Paterson Aimee S, Coburn Bryan, Poutanen Susan M
Affiliations: Department of Infection Prevention and Control (Hota), University Health Network; Department of Medicine (Hota, Coburn), University of Toronto; Department of Microbiology (Surangiwala, Paterson, Poutanen), University Health Network/Sinai Health System; Toronto General Hospital Research Institute (Coburn); Department of Laboratory Medicine and Pathobiology (Poutanen), University of Toronto, Toronto, Ont.
CMAJ Open. 2018 Apr 18;6(2):E184-E190. doi: 10.9778/cmajo.20170109.
There is growing evidence that fecal microbiota transplantation (FMT) is an effective treatment for recurrent infection, but little guidance exists for implementation of FMT programs. The objective of this study is to describe the program characteristics and protocols of 9 planned or operating FMT programs in the Southern Ontario Fecal Microbiota Transplantation (SOFT) Movement, to help guide future FMT program implementation.
A 59-item survey was administered electronically to clinical leads of the SOFT Movement on June 2, 2016. The survey evaluated 7 domains: FMT program characteristics, FMT recipients, donor screening/selection, transplant manufacturing, FMT administration, good manufacturing procedures/biosafety procedures and infection-control procedures. We used descriptive statistics to analyze quantitative data.
All 9 programs responded to the survey: 6 were active, 1 had FMT standard operating procedures developed but did not have clinical experience, and 2 were in the process of forming FMT programs. All 6 active programs performed FMT in adult patients with infection. About 1300 FMT procedures were performed between 2003 and 2016. Five of the 6 operating programs administered the preparation via enema. Programs were driven primarily by physicians. All programs used universal FMT donors and followed Health Canada's screening guidelines, with considerable variability in screening frequency (every 3-6 mo) and modality. Locations for transplant preparation and manufacturing protocols varied across programs. Stool mass for FMT ranged from 20 g to 150 g, and transplant volume ranged from 25 mL to 300 mL.
The experience of this high-volume regional FMT network highlights current challenges in FMT program development, including a high reliance on physicians and the costly nature of donor screening. Standardization and optimization through development of regional centres of excellence for FMT donor recruitment and administration should be explored.
越来越多的证据表明,粪便微生物群移植(FMT)是治疗复发性感染的有效方法,但对于FMT项目的实施几乎没有指导意见。本研究的目的是描述安大略省南部粪便微生物群移植(SOFT)运动中9个计划或正在运行的FMT项目的项目特征和方案,以帮助指导未来FMT项目的实施。
2016年6月2日,通过电子方式向SOFT运动的临床负责人发放了一份包含59个条目的调查问卷。该调查评估了7个领域:FMT项目特征、FMT接受者、供体筛查/选择、移植制备、FMT给药、良好生产规范/生物安全程序和感染控制程序。我们使用描述性统计分析定量数据。
所有9个项目都对调查做出了回应:6个项目在运行,1个项目制定了FMT标准操作程序但没有临床经验,2个项目正在组建FMT项目。所有6个运行中的项目都对成年感染患者进行了FMT。2003年至2016年期间共进行了约1300例FMT手术。6个运行中的项目中有5个通过灌肠给药。项目主要由医生推动。所有项目都使用通用的FMT供体,并遵循加拿大卫生部的筛查指南,筛查频率(每3 - 6个月)和方式存在很大差异。不同项目的移植制备地点和生产方案各不相同。FMT的粪便量从20克到150克不等,移植体积从25毫升到300毫升不等。
这个高容量区域FMT网络的经验凸显了FMT项目开发中当前面临的挑战,包括对医生的高度依赖以及供体筛查的高成本性质。应探索通过建立FMT供体招募和管理卓越区域中心来实现标准化和优化。